Approximately one-fifth of the world's population suffer from some level of nutritional iron deficiency. Young children and women of childbearing age are the most adversely affected by anemia and other iron deficiency related conditions. Anemia during pregnancy can lead to risk of premature labor, (Lieberman et al., Am.J.Obstet.Gyn. 159:107-114) and an increased perinatal morbidity and mortality, (Bothwell et al., In Iron Metabolism in Man, 1979). The development of children may also be impaired having an effect on their later performance in schools. Iron deficiency can also adversely affect laborers which results in impaired productivity, (Edgerton et al., Brit. Med.J. 2:1546-9, 1979).
Heme iron, which is derived primarily from hemoglobin and myoglobin in meat, is transferred as intact porphyrin complex to intestinal cells, where the heme oxygenase enzyme rapidly releases the iron. It blends with other iron taken up by the cell before the regulated transfer to the blood stream occurs. This form of iron is readily absorbed and is generally not affected by the contents of the meal with which the heme containing food is consumed. The nonheme iron has a heterogenous origin, being derived from vegetable foods and inorganic forms of iron, and can be used to fortify foods to increase the level of iron present in the food.
Non-heme iron, which is derived from plant foods and fortified foods is not as well absorbed as heme (meat) iron. Furthermore, beverages such as coffee and tea consumed at meal time and other components can contribute to poor absorption of non-heme iron.
The addition of ascorbic acid or vitamin C can enhance the iron absorption in the diet, generally without affecting consumer acceptability. However, ascorbic acid is expensive compared to iron fortification and when exposed to oxygen and moisture can be unstable under storage conditions. In cases where food preparation involves baking, prolonged boiling or reheating, ascorbic acid is incompatible with iron fortification.
The most efficient and cost-effective way of preventing and treating iron deficiency is to fortify food products with a form of iron that provides for adequate absorption.
Recently, a sodium ferric ethylenediaminetetraacetic acid complex (hereinafter "ferric EDTA") has been studied primarily for fortification purposes due to its chemical stability, (See Fe Iron EDTA for Food Fortification--A report of the International Nutritional Anemia Consultative Group). It has been found to be suitable for fortifying foods that require prolonged storage or high temperatures during preparation.
Ferric EDTA is a pale-yellow water-soluble powder that can be added to many food vehicles. In addition, when ferric EDTA is consumed with foods containing large quantities of absorption inhibitors, iron is protected from agents which inhibit its absorption. Ferric EDTA has been reported to be two to three times more bioavailable than iron presented as a FeSO.sub.4 complex in some diets. Furthermore, ferric EDTA is more stable under adverse storage conditions and is unaffected by cooking.
Other known uses of ferric EDTA, under experimental conditions, are found in food ingredients or condiments, i.e., fish sauce in Thailand (Garby et al., 1974, Ann.Tro.Med.Parasitol. 68: 467-76), curry powder in South Africa (Macphail et al. Experimental Fortificants, in: Clydesdale FM et al. eds. Iron Fortification of Foods, 1985), Egyptian flat bread (Guindi et al., Brit.J. Nutr. 59:205-213, 1988), sugar in Guatemala (MacPhail et al., Br. J. Nutr. 45: 215-227, 1981). Absorption of iron in dietary foods such as flat breads has also been studied in Guindi et al., 1988.
This is the first known use of ferric EDTA fortification in a ready-to-eat cereal. The R-T-E cereal product is often added to a liquid, e.g., milk, and then consumed without reheating or cooking. The R-T-E cereal product is prepared with ferric EDTA by either incorporating it into the cereal mix prior to cooking or by spraying a ferric EDTA solution onto the finished cereal product.
It has been found that ferric EDTA provides for the best combined results for iron fortification, in terms of bioavailability, brightness characteristics, metallic offtaste and oxidative stability after exposure to hot room tests. It was found that ferric EDTA fortification results in improved bioavailability, excellent brightness tests, little metallic offtaste and excellent oxidative stability.
These unexpected properties for the ferric EDTA fortified R-T-E cereal product described above have not been established prior to this application. Surprisingly, the addition of ferric EDTA does not alter the intensity of the brightness or flavor of the finished cereal product.
Thus, it is a principal object of this invention to provide for a ready-to-eat cereal which is fortified with a ferric EDTA complex. The use of ferric EDTA as an iron fortificant in a R-T-E cereal produces a product which is organoleptically acceptable to consumers. The color, odor, and taste of the product is not adversely affected by the addition of the ferric EDTA fortificant and the bioavailability of the iron in the R-T-E cereal product appeared not be affected by the constituents of cereals which might inhibit the absorption of other forms of iron.
It is a further object of the invention to provide for fortifying a ready-to-eat cereal with ferric EDTA in combination with an additional source of iron, i.e., reduced iron, ferrous sulfate.
It is a further object of the invention to provide a method to prevent or to treat iron-deficiency anemia by administering the ready-to-eat cereal of the invention to individuals or population groups in need of such treatment.